磺苄西林钠有关物质研究  

Determination of impurities in sulbenicillin sodium

作　　者：彭琳 艾俊涛 廖彬 刘雁鸣 PENG Lin;AI jun-tao;LIAO bin;LIU Yan-ming(Hunan Testing Institute for Medical Devices,Changsha 410014;Hunan Institute for Drug Control,Changsha 410011)

机构地区：[1]湖南省医疗器械检验检测所,长沙410014 [2]湖南省药品检验研究院,长沙410011

出　　处：《中南药学》2021年第10期2144-2148,共5页Central South Pharmacy

摘　　要：目的建立了液相色谱法分析磺苄西林钠特定杂质及杂质谱。方法采用Acclaim 120 C_(18)色谱柱,以0.02 mol·L^(-1) 磷酸二氢钾溶液-甲醇为流动相,流速为1.0 mL·min^(-1);通过DAD检测器测定后进行样品杂质谱的比较分析。结果磺苄西林钠与有关物质分离良好,6-氨基青霉烷酸在1.113~11.130 μg·mL^(-1) 、左旋磺苯乙酸在1.217~12.170 μg·mL^(-1) 、磺苯乙酰氯在1.284~12.840 μg·mL^(-1) 与峰面积的线性关系良好。结论磺苄西林钠特定杂质检测及杂质谱的建立为磺苄西林钠原料及其注射液质量控制提供参考依据。Objective To establish an HPLC method for the determination of specific impurities and impurity profile in sulbenicillin sodium.Methods The HPLC separation was performed on an Acclaim C18 column and a mobile phase consisting of 0.02 mol·L^(^(-1) ) monopotassium phosphate aqueous solution and methanol at a flow rate of 1.0 mL·min^(-1) .The comparation of impurity profile of samples were analyzed by DAD.Results The related substances in sulbenicillin sodium were separeted well.The linear relationship between the concentration and the peak area of 6-APA,l-sulfophenylacetic acid and sulfonyl chloride was good at 1.113~11.130μg·mL^(-1) ,1.217~12.170μg·mL^(^(-1) ) and 1.284~12.840μg·mL^(-1) ,respectively.Conclusion The established method is effective for the determination of the specific impurities in sulbenicillin sodium and the impurity profile,which provides a reference for the quality control of sulbenicillin sodium and its injection.

关 键 词：磺苄西林钠 有关物质 杂质谱 

分 类 号：R927[医药卫生—药学]